The present invention pertains to compositions containing dioctyl calcium sulfosuccinate, also known as S-calcium bis(2-ethylhexyl) sulfosuccinate. More particularly, this invention pertains to compositions comprising a solution of dioctyl calcium sulfosuccinate in a mixture of non-aqueous solvents. The invention also pertains to an improved dosage unit comprising a gelatin capsule containing said compositions.
Compositions comprising dioctyl calcium sulfosuccinate dissolved in oils, such as corn oil, peanut oil, cotton seed oil, and the like, as well as equivalent non-aqueous solvents such as polyethylene glycols 200-400, containing up to 10% by volume of glyceryl monooleate in soft gelatin capsules are disclosed by Klotz in U.S. Pat. No. 3,035,973 as fecal softeners. However, the preferred compositions of Klotz, which utilize corn oil, cannot be stored at temperatures below 10.degree. C. without crystallizing, or solidifying. Furthermore, allowing the solidified or crystallized compositions to warm to room temperature does not cause them to revert to free-flowing fluids. Often the compositions disclosed by Klotz gel or crystallize under ambient conditions (20.degree.-25.degree. C.).
There is a need, therefore, for a composition comprising dioctyl calcium sulfosuccinate in a non-aqueous solvent or mixture of solvents which will either resist solidification or crystallization at temperature below 10.degree. C., or revert to clear free-flowing fluids on warming to ambient conditions. Preferably, the solution should neither solidify nor crystallize on prolonged storage below 10.degree. C. and be a clear free-flowing fluid under ambient conditions. There is also a need for a dosage unit containing dioctylsulfosuccinate in a non-aqueous solvent or mixture of solvents in a gelatin capsule which will either resist solidification or crystallization at temperatures below 10.degree. C. or revert to clear free-flowing fluids on warming to ambient conditions.